Vascular closure device suture tension limiting and indication mechanism

ABSTRACT

Disclosed is an apparatus and system that includes an elongated body, a vascular closure device that can occlude a hole in a vessel wall coupled to a distal end of the elongated body, a sleeve assembly and a biasing member arranged to elastically deform coupled between the elongated body and the sleeve assembly, wherein the vascular closure device is pliant and is deformable to fit with the sleeve assembly but is too large to fit within the sleeve assembly without deforming it and where application of tension to the elongated body by retracting the sleeve assembly away from the deployed vascular closure device elastically deforms the biasing member and exerts a force on the vascular closure device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/180,625 filed Feb. 14, 2014, which claims the benefit ofU.S. Provisional Patent Application, Ser. No. 61/787,209 filed Mar. 15,2013, which is hereby incorporated by reference.

FIELD

The present disclosure relates generally to systems and methods forsealing an opening in the body of a patient.

BACKGROUND

This disclosure concerns apparatuses and methods useful for sealing anopening in a body wall, such as an access opening in the wall of a bloodvessel or a fistula. In particular, apparatus and methods are disclosedfor closing and allowing healing of an opening in a tissue wall, whethermade during a medical procedure (e.g. those in which apparatus ormedicaments are introduced into tissue) or naturally occurring (e.g. asa result of malformation or disease).

It has long been known to insert devices into bodily vessels or conduitsto provide therapy or for diagnostic purposes. For example, incardiovascular medicine, it is known to insert catheters, stents andother devices into a patient's vascular system in order to evaluate ortreat the patient. In the case of percutaneous transluminal angioplasty(PTA), an opening is made through the patient's skin and into a large orrelatively large blood vessel, such as the femoral artery, and a balloonis inserted into the vessel and advanced to the location where vesselnarrowing has occurred, such as by atherosclerosis. Similar proceduresare used to implant stents to maintain flow through blood or otherbodily vessels or ducts. In accessing the interior of a blood vessel,the interventionist or medical professional may breach the integrity ofthe vessel. A variety of devices (e.g. needles, guide wires, cannula)are known to open a path into a vessel via a percutaneous opening orother approach. Additional devices or implants can be moved through suchdevices, or through sleeves or cannula placed in the opening to keep itopen, and into the vessel.

When the procedure is concluded, a cannula or other access device isremoved from the vessel, leaving an opening in the vessel. If thearteriotomy is not adequately closed, a subcutaneous hematoma will form.The medical professional may therefore take steps to close the openingin the vessel. In some cases, the opening may be sutured closed, butsuch action can be very difficult in close quarters, and manyvessel-accessing procedures are intended to be minimally-invasive toreduce tissue damage. It is also known to apply constant, firm externalpressure to the opening in the vessel, particularly if it is a bloodvessel, to allow the body's natural coagulation and healing processes towork. In cases in which angioplasty or similar treatment has takenplace, however, commonly an anticoagulant has been administered to thepatient, making natural closing of the opening in the vessel wall alonger or more difficult process. Maintaining physical pressure on arelatively large blood vessel for a time period sufficient for naturalclosure also presents at least inconvenience and discomfort to thepatient in having to remain motionless and submit to that pressure, andthere is the risk that too much pressure can damage the vessel ortissues that rely on continued flow through it.

Therapies for closing naturally-occurring fistulae or other undesirablebodily openings are also known. Treatments have included closure bysuturing or by covering the opening, and by other surgical techniques.Frequently these therapies have required open surgeries with theirattendant difficulties.

Devices have been created for inserting closures into a blood vessel oron its exterior that are designed to block the opening and/or soak upfluids that escape the vessel, or are present in the opening through theskin leading to the vessel. Such devices have, however, provenunsatisfactory in many respects, as have therapies for closingnaturally-occurring openings in tissue. Needs therefore exist forimproved and/or alternative devices and systems for inserting a closurefor an opening in tissue that produces a seal without significantlyblocking adjacent flow where desired (e.g. through a blood vessel), andfills the opening where that is desirable.

SUMMARY

In certain aspects, the present disclosure provides an apparatus thatincludes a sleeve assembly having a bore that is adapted to be insertedinto an introducer, a pliant vascular closure device that deforms to fitwithin a bore of the sleeve assembly, an elongated body couple to thevascular closure device and a biasing member that connects the elongatedbody to the sleeve assembly so when the vascular closure device isdeployed with a vessel in the body of the patient, retracting the sleeveassembly away from the patient's body applies tension to the elongatedbody and elastically deforms the biasing member and exerts a force onthe vascular closure device.

Application of a conforming force through the elongated body may deformthe vascular closure device against the vessel wall. Conforming thevascular closure device against the vessel wall may fluidly seal thevessel wall. The vascular closure device may be dome shaped. The sleeveassembly may include a flange that abuts the introducer so that theintroducer may be gripped to retract the sleeve assembly.

The biasing member may be substantially more pliant than either theelongated body or the sleeve assembly. The elongated body may optionallyinclude an indicator located on the elongated body to be obscured whenthe elongated body is not displaced with respect to the sleeve assemblyand discernible when a conforming force is applied to the elongated bodythrough the biasing member and the sleeve assembly. The indicator mayoptionally include a conforming graduation and/or a distortinggraduation that indicates when either a conforming force or a distortingforce is applied to the vascular closure device.

The biasing member may be a compressible member positioned between thesleeve assembly and an end protrusion on the elongated body or thebiasing member may be a tensile member positioned on the end of theelongated body.

The sleeve assembly may define a bore that can hold the vascular closuredevice and the elongated body while permitting longitudinal displacementof the vascular closure device and the elongated body with respect tothe sleeve assembly.

A packing member may optionally be arranged on the elongated member. Thepacking member may be longitudinally displaceable with respect to theelongated member.

The sleeve assembly may be configured to be insertable into the lumen ofan introducer sheath, such as an introducer sheath used to gain accessto blood vessels.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a system for closing ahole in a vessel wall, the system including a biasing member, a packingmember, an elongated body, a sleeve and a vascular closure device.

FIG. 2 is a cross-sectional view of the system illustrated in FIG. 1.

FIG. 3 is a cross-sectional view of the system illustrated in FIG. 1incorporating an alternative embodiment of the biasing member.

FIG. 4 is a cross-sectional side view of a vascular closure devicecoupled to an elongated body in an unconformed configuration.

FIG. 5 is a side elevational view of the vascular closure device of FIG.4 under a conforming force.

FIG. 6 is a side elevational view of the vascular closure device of FIG.4 under a deforming force.

FIG. 7 is a side elevational view of a second alternate embodiment ofthe FIG. 1 biasing member.

FIG. 8 is a side elevational view of a third alternate embodiment of theFIG. 1 biasing member.

FIG. 9 is a side elevational view of a fourth alternate embodiment ofthe FIG. 1 biasing member.

FIG. 10 is a side elevational view of a fifth alternate embodiment ofthe FIG. 1 biasing member.

FIG. 11 is a side elevational view of a sixth alternate embodiment ofthe FIG. 1 biasing member.

FIG. 12 is a side elevational view of a seventh alternate embodiment ofthe FIG. 1 biasing member.

FIG. 13 is a side elevational view of an eighth alternate embodiment ofthe FIG. 1 biasing member.

FIG. 14 is a side elevational view of a ninth alternate embodiment ofthe FIG. 1 biasing member.

FIG. 15 is a cross-sectional view of the FIG. 1 system in a firstposition, with the sleeve assembly inserted into an introducer.

FIG. 16 is a cross-sectional view of the system illustrated in FIG. 15in a second position, with the vascular closure device and insertionsheath advanced into the introducer.

FIG. 17 is a cross-sectional view of the system illustrated in FIG. 15in a third position, with the vascular closure device advanced out ofthe introducer into a lumen of a vessel.

FIG. 18 is a cross-sectional view of the system illustrated in FIG. 15,in a fourth position, with the vascular closure device retracted and incontact with an inner surface of the vessel wall.

FIG. 19 is a cross-sectional view of the system illustrated in FIG. 15in a fifth position, with the elongated body partially deployed out ofthe introducer vascular closure device.

FIG. 20 is a cross-sectional view of the system illustrated in FIG. 15in a sixth position, with the elongated body fully deployed out of theintroducer.

FIG. 21 is a cross-sectional view of the system illustrated in FIG. 15in a seventh position, with tension applied to the elongated bodyplacing the biasing member in compression and applying a conformingforce to the vascular closure device through the elongated body.

FIG. 22 is a cross-sectional view of the system illustrated in FIG. 15in an eighth position, with the packing member advanced over theelongated body and abutting against the outer surface of the vesselwall.

FIG. 23 is a cross-sectional view of the system illustrated in FIG. 15in a ninth position, with the elongated body severed and removed,leaving the vascular closure device in situ.

FIG. 24 is a cross-sectional view of the system illustrated in FIG. 15in a tenth position, with tension applied to the elongated body placingthe biasing member in compression and applying a deforming force to thevascular closure device through the elongated body.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates.

With respect to the specification and claims, it should be noted thatthe singular forms “a”, “an”, “the”, and the like include pluralreferences unless expressly discussed otherwise. As an illustration,references to “a device” or “the device” include one or more of suchdevices and equivalents thereof. It also should be noted thatdirectional terms, such as “up”, “down”, “top”, “bottom”, and the like,are used herein solely for the convenience of the reader in order to aidin the reader's understanding of the illustrated embodiments, and it isnot the intent that the use of these directional terms in any mannerlimit the described, illustrated, and/or claimed features to a specificdirection and/or orientation.

The description below will focus on use in blood vessels of a human oranimal, but it will be understood that the structures disclosed hereinhave application to a number of other vessels or conduits or bodilycavities. Closure or treatment of undesired openings in a variety oftissues can be performed with structures and methodology as disclosed.Examples of other applications include sealing primary and/or secondaryopenings of a fistula with healing or correction (e.g., filling) of thefistula between the openings. Such fistulae may include vesicovaginalfistulae, which are abnormal passages between the vagina and bladder.

Referring now to FIGS. 1 and 2, system 100 for closing an opening in awall of a vessel, conduit or other bodily cavity is illustrated. System100 includes sleeve assembly 160, elongated body 200, and, in someinstances, packing member 130, pushing member 132, vascular closuredevice 230 and introducer 240.

In the illustrated embodiment, sleeve assembly 160 includes outer sheath110 and an insertion sheath 140. Outer sheath 110 has proximal endregion 112, distal end region 114 and wall 116. Wall 116 has innersurface 118 and outer surface 120. Inner surface 118 defines lumen 122that is constructed and arranged to receive vascular closure device 230and/or insertion sheath 140. Insertion sheath 140 includes proximal endregion 142, distal end region 144, and wall 146 having inner surface 148and outer surface 150. Inner surface 148 of wall 146 defines lumen 152constructed and arranged to retain elongated body 200 of system 100.Outer surface 150 is constructed and arranged to slidably couple withinner surface 118 of wall 116 of outer sheath 110 so as to allowinsertion sheath 140 to slide within lumen 122 of outer sheath 110.

Wall 116 also forms a flange 124 on outer surface 120 positioned nearproximal end region 112 of outer sheath 110. Flange 124 defines proximalsurface 126 and distal surface 128. Wall 146 of insertion sheath 140defines flange 154 having proximal surface 156 and distal surface 158.Proximal surface 126 and distal surface 158 are constructed and arrangedto limit the distance that insertion sheath 140 is insertable into outersheath 110.

Elongated body 200 is a flexible body constructed for transferringtensile loads. Elongated body 200 may be a single strand of material orelongated body 200 may include one or more plies or strands that may betwisted or braided together. Elongated body 200 may be a generally solidbody manufactured or molded to a desired shape. Elongated body 200 iscomparatively ridged in tension but may be too flexible to providecompressive strength. Elongated body 200 may be a type of suturematerial or a variety of other elongated materials capable of extendingwithin a body passageway, vessel or cavity, including variousbiodegradable and non-biodegradable cords, filaments, chains, strings,elongate graft members, wires and other similar objects havingrelatively slender profiles for extending through a tract or otherpassageway or void in patient tissue. In some instances, a somewhatheftier elongated structure such as a generally solid biodegradable ornon-biodegradable three-dimensional body may be made to extend through abodily opening or passageway. Such a structure may have more heft andbulk than a thread or filament.

Vascular closure device 230 may be affixed to distal end region 204 ofelongated body 200. Vascular closure device 230 may be a separatecomponent from elongated body 200 or vascular closure device 230 may beunitarily constructed with elongated body 200. Vascular closure device230 may be any implement used to cover and occlude a hole 1016 in avessel wall. As will be apparent to one of ordinary skill in the art, avariety of vascular closure devices 230 may be used with the disclosedsystems. For example, a domed-shaped sealing member 232 having asemi-elliptical shape in an unstressed configuration may be used. Aswill be appreciated by one of ordinary skill in the art, vascularclosure devices 230 may have different shapes, different dimensions,different materials, and/or different properties. System 100 may beconstructed to position and conform a vascular closure device 230 thatmay be left in situ after a procedure.

Biasing member 180 is a pliant body located between elongated body 200and sleeve assembly 160. As shown in FIG. 2, biasing member 180 isspherical with passage for elongated body 200 to pass through. Biasingmember 180 is positioned on elongated body 200 between protrusion 210and sleeve assembly 160. Biasing member 180 is constructed and arrangedto act as a spring when compressed between protrusion 210 and proximalsurface 156 as described below. Specifically, biasing member 180 isconstructed of an elastic material that can elastically deform whencompressed as described. For example, biasing member 180 may beconstructed from a soft rubber, silicone or an elastomeric material.When compressed, biasing member 180 exerts a force substantiallyproportional to the displacement of biasing member 180 that seeks toreturn biasing member 180 to its unstressed state, as illustrated inFIG. 2.

Biasing member 180 may be constructed and arranged such that the amountof force required to compress a particular biasing member 180 issubstantially equivalent to a conforming force for a particular vascularclosure device 230. Biasing member 180 may be varied to account for aspecific vascular closure device 230 used in conjunction with aparticular biasing member 180.

Elongated body 200 includes protrusion 210 located in proximal endregion 202 of elongated body 200. Protrusions 210 can be of a variety ofshapes, including barbs, knots, frusto-conical segments, or flatsurfaces, to name a few non-limiting examples. Additionally, protrusion210 may be made monolithically with elongated body 200 or separate fromelongated body 200 and coupled to it later. Protrusion 210 may beaffixed to elongated body 200 or protrusion 210 may be slidingly engagedon elongated body with protrusion 212 on elongated body 200 keepingprotrusion 210 on the end of elongated body 200.

Elongated body 200 may include a locking member 222 positioned neardistal end region 204. Locking member 222 may be constructed andarranged to secure a second vascular closure device positioned againstouter surface 1012 of a vessel wall 1008 (opposite of vascular closuredevice 230) and/or to secure a packing member 130 in and/or around hole1016 in vessel wall 1008. In many embodiments, locking member 222 isconstructed and arranged so as to be capable of sustaining a conformingforce between vascular closure device 230 and packing member 130.

Elongated body 200 may optionally include indicator 234. Indicator 234may be an integral part of elongated body 200 or indicator 200 may becoupled to elongated body 200. Indicator 234 occupies a fixed relativelongitudinal position on elongated body 200 and is arranged to becomediscernible to an operator when biasing member 180 is deformed, forexample, by protruding from the end of sleeve assembly 160.

Elongated body 200 coupled to vascular closure device 230 is constructedand arranged so as to be capable of applying a conforming force tovascular closure device 230. The conforming force is an amount of forcethat conforms vascular closure device 230 to inner surface 1010 ofvessel wall 1008, such that vascular closure device 230 substantiallyoccludes hole 1016 in vessel wall 1008 and substantially seals hole 1016to prevent or substantially reduce any blood from escaping vessel 1006.

Illustrated in FIG. 3 is system 102 an alternative embodiment of system100. System 102 is similar to system 100 and shares many components,which are referenced using the same reference numerals used in FIG. 2 torefer to system 100. The major difference between systems 102 and 100 isthat, in system 102, biasing member 180 is omitted and is replaced withelastic region 220 on elongated member 200. Elastic region 220 islocated on elongated member 200 between protrusion 210 and indicator234. Rigid region 206 represents the remaining portion of elongatedmember and includes at least the region between indicator 234 andvascular closure device 230. Elastic region 220 is substantially morepliant than rigid region 206. Elastic region 220 is constructed toelastically deform when tension is applied such that elastic region 220lengthens longitudinally when tensioned and exerts a counter force thatis approximately proportional to the relative longitudinal lengtheningof elastic region 220. Elastic region 220 may be made of a soft rubber,silicone or elastomeric monofilament for example. System 102 otherwisefunctions in a similar way as described herein with regard to system100.

Illustrated in FIG. 4 is vascular closure device 230 in an unstressedconfiguration. As a conforming force is applied to vascular closuredevice 230 by elongated body 200, vascular closure device 230 deformsinto a conforming configuration, as illustrated in FIG. 5. Vascularclosure device 230 may be constructed and arranged such at theconforming configuration illustrated in FIG. 5 substantially seals hole1016 to prevent or substantially reduce any liquid, such as blood, frompassing through hole 1016.

FIG. 6 illustrates a deformed configuration that may or may notsubstantially seal hole 1016. The amount of force applied to vascularclosure device 230 illustrated in FIG. 6 is greater than the amount offorce applied to vascular closure device 230 illustrated in FIG. 5.FIGS. 5 and 6 illustrate varying ranges of deformation that may beapplied to vascular closure device 230 while substantially sealing hole1016. It should be understood that FIGS. 4-6 show exaggerated forms ofvascular closure device 230 for illustrative purposes. Other vascularclosure devices (not illustrated) having varying shapes as appropriatefor particular applications may be used with system 100. It should alsobe understood that FIGS. 4-6 illustrate only a linear cross-section ofvessel wall 1008. In use, vascular closure device may interact with amore complex geometry, such as a cylindrical vessel, causing thegeometry of the vascular closure device to substantially conform to acomplex shape.

A force that is greater than the conforming force can be applied tovascular closure device 230 through elongated body 200. For purposes ofthis application, such a force is referred to as a distorting force. Adistorting force is the lesser of the amount of force necessary todeform vascular closure device 230 beyond a shape that occludes hole1016 in vessel wall 1008, the amount of force necessary to pull vascularclosure device 230 through hole 1016 in vessel wall 1008, and/or theamount of force necessary to damage vascular closure device 230 and/orvessel wall 1008. In some conditions, the deformed configuration ofvascular closure device 230 illustrated in FIG. 6 may be a distortingforce. In other conditions, the deformed configuration of vascularclosure device 230 illustrated in FIG. 6 may be a conformingconfiguration.

FIGS. 7-14 illustrate alternative embodiments of biasing member 180including biasing member 181, biasing member 182, biasing member 183,biasing member 184, biasing member 185, biasing member 186, biasingmember 187 and biasing member 188. Biasing members 181, 182, 183, 184,185, 186, 187 and 188 are alternative geometries for biasing member 180that can be used, in conjunction with material selection, to adjust theamount of force that can be exerted by biasing member 180 and thedeformation distance available.

FIGS. 1 and 15-24 illustrate an embodiment of introducer 240 that may beincluded in system 100 or introducer 240 may be a third party catheterintroducer, for example. Introducer 240 comprises a proximal end region242, a distal end region 244 and a wall 264 having an inner surface 248and an outer surface 250. Inner surface 248 defines a lumen 252. Outersheath 110, insertion sheath 140, and/or vascular closing device 230 areconstructed and arranged to be insertable into lumen 252. In someinstances, introducer 240 may include seal member 254, such as ahemostasis valve, positioned in proximal end region 242.

In some embodiments, system 100 includes packing member 130, pushingmember 132, and locking member 222, each disposed in a slidingarrangement on elongated body 200. Packing member 130 may be positionedwithin insertion sheath 140 proximal to vascular closure device 230, andsurrounding elongated body 200. Packing member 130 and locking member222 are slidably engaged over elongated body 200 and pushing member 132is arranged for an operator to apply force to locking member 222 againstpacking member 130 to move packing member 130 against outer surface 1012of vessel wall 1008.

In the embodiments including locking member 222, locking member 222 maybe used to retain packing member 130 in position against vessel wall1008. Locking member 222 may be constructed and arranged to engageelongated body 200 in a manner that secures locking member 222 frommoving along elongated body 200 in a proximal direction. For example,locking member 222 may engage a portion of elongated body 200 in distalend region 204 and apply a compressive force to packing member 130. Insome instances, locking member 222 may engage protrusion 224 in distalend region 204 of elongated body 200. As packing member 130 is movedadjacent to outer surface 1012 of vessel wall 1008 by relative movementof pushing member 132, locking member 222 may pass over a portion ofpacking member 130 that resists proximal movement of locking member 222and packing member 130 away from vessel wall 1008. In other embodiments,locking member 222 may be constructed to permit relative movement withelongated body 200 in a single direction only. In such an embodiment,features such as protrusion 224 may optionally be omitted. System 100may be constructed and arranged such that the force that packing member130 exerts on locking member 222 is communicated through elongated body200 to vascular closure device 230 to retain vascular closure device 230in a conformed configuration.

The above mentioned components may be made using materials and methodsapparent to one of ordinary skill in the art. For example, elongatedbody 200, vascular closure device 230, and/or packing member 130 can bemade of any material suitable for implantation within the body of thepatient. Appropriate materials include synthetic materials and a grownor harvested tissue, such as an extracellular matrix material (ECM) suchas porcine small intestinal submucosa (SIS). In some instances, spongyor foam materials or other forms of materials are used. Preparation ofsuch materials is disclosed in U.S. patent application Ser. No.12/489,199 (filed Jun. 22, 2009).

As noted above, in particular embodiments the material may be acollagenous extracellular matrix material such as SIS, and it is treatedto partially denature and expand the native collagenous structure, forexample with sodium hydroxide, to provide porosity and/or foamcharacteristics when dried. In certain embodiments, the extracellularmatrix material can be processed to be medically acceptable whileretaining a native collagenous microarchitecture (e.g. a native sheetform) and endogenous bioactive substances from an animal source tissue,such as a porcine, ovine, bovine or equine source tissue. Suchendogenous substances can for example include one, some, or all ofgrowth factors (e.g., Fibroblast Growth Factor-2), glycosaminoglycans,and proteoglycans. The extracellular matrix material can be treated witha chemical crosslinking agent, for example glutaraldehyde or acarbodiimide, to add crosslinks over and above any native crosslinkspresent, or can lack any such treatment. In other embodiments, elongatedbody 200, vascular closure device 230, and/or packing member 130 cancomprise a reconstituted collagen sheet or foam, optionally crosslinkedwith a chemical crosslinker such as those discussed above.

The portions of system 100 that are not implanted into the body of thepatient may be made of any number of materials. For example, outersheath 110, pushing member 132, insertion sheath 140, sleeve assembly160, and/or introducer 240 may be made of plastic or other suitablematerial. In some instances the material may need to maintain itsrigidity over a sufficient length (e.g., 10 to 20 cm or more), so thatan operator may manipulate a proximal portion and impart movement of adistal portion, such as with pushing member 132. For example, whenadvancing packing member 130 with pushing member 132, the operator canmanipulate such longer embodiments of pushing member 132 from outside ofthe patient, with tactile feedback indicated passage of packing member130 and/or locking member 222 past protrusion 224 on elongated body 200.

Variations of the above described embodiments, as will be apparent toone of ordinary skill in the art, are contemplated by the presentdisclosure.

Use of system 100 will now be described with respect to closing andrepairing an opening in a wall of a blood vessel. As noted previously,it is to be understood that similar usages can be made in other bodytissues (e.g., bile or other ducts), or other vessels, conduits orwalls. For example, in use with fistulae (e.g., vesciovaginal fistula),seal(s) as described herein may be placed and held over fistula openingsand against tissue substantially as described below, with packingmembers within the fistula to assist with healing or correction of thefistula.

Reference to the following exemplary method of use will be made withregard to FIG. 15 illustrating vessel 1006 positioned beneath tissue1000 such as skin 1002 and/or muscle/fat 1004 of the body of a patient.Vessel 1006 comprises vessel wall 1008 having inner surface 1010, outersurface 1012, and inner surface defining lumen 1014 extending throughvessel 1006.

A surgeon or other medical professional performs and completes desiredprocedure(s) that involve access to blood vessel 1006 through hole 1016in wall 1008 (e.g., balloon catheterization or stenting procedures). Ifa sheath, cannula or other access device or portal was used for theprocedure(s), it can be left in vessel 1006, and system 100 describedabove may be inserted through it. If no such access device is present,or if a change of access device is advisable, introducer 240 may beplaced in hole 1016 by using a dilator with an introducer sheath so thatthe distal end of introducer 240 is inside vessel 1006. Seal member 254may provide a barrier preventing blood or other fluid from exitingthrough lumen 252 of introducer 240 from proximal end region 242.

Also as illustrated in FIG. 15, after access is gained to lumen 1014 ofvessel 1006 within the body of the patient and vessel 1006 has been usedto provide therapy and/or for diagnostic purposes, system 100, preparedas noted above, may be inserted into lumen 252 of introducer 240 andadvanced distally towards vessel 1006. As outer surface 120 of outersheath 110 slides along inner surface 248 defining lumen 252, distalsurface 128 of flange 124 of outer sheath 110 contacts a portion ofproximal end region 242 of introducer 240 and prevents further insertionof outer sheath 110 within lumen 252 of introducer 240.

If outer sheath 110 is shorter in length than introducer 240, theninsertion sheath 140, elongated body 200 and the vascular closure devicemay be advanced through lumen 122 of outer sheath 110 so as to positionvascular closure device 230 and/or portions of insertion sheath 140and/or elongated body 200 within lumen 252 of introducer 240 as shown inFIG. 16.

As shown in FIG. 17, insertion sheath 140 may be advanced further so asto extend vascular closure device 230 out of lumen 252 and into lumen1014 of vessel 1006, allowing vascular closure device 230 to expand intoan expanded configuration within lumen 1014. After vascular closuredevice 230 has expanded into an expanded configuration, sleeve assembly160, elongated body 200, and/or introducer 240 are/is withdrawn.

As shown in FIG. 18, as sleeve assembly 160 and/or introducer 240 arewithdrawn from vessel 1006. As elongated body 200 is withdrawn fromvessel 1006, vascular closure device 230 is pulled against inner surface1010 of vessel wall 1008 thereby covering hole 1016 and elongated body200 is pulled tight.

As illustrated in FIGS. 19 and 20, the operator continues to withdrawsleeve assembly 160 and/or introducer 240 along the length of elongatedbody 200 until protrusion 210 abuts biasing member 180 and packingmember 130, locking member 222 and pushing member 132 are fully deployedout of sleeve assembly 160 and/or introducer 240. In addition, indicator234 is positioned near distal end region 114 of outer sheath 110.

As shown in FIG. 21, continued movement of sleeve assembly 160 and/orintroducer 240 away from hole 1016 compresses biasing member 180 betweenprotrusion 210 and proximal surface 156 of flange 154 on insertionsheath 140 and pulls vascular closure device 230 against inner surface1010 deforming vascular closure device 230 to substantially seal hole1016 against passage of a fluid such as blood through hole 1016. Asbiasing member 180 compresses, indicator 234 extends beyond distal endregion 114 of outer sheath 110. Indicator 234 may provide an operatordiscernable visual evidence that a conforming force has been applied tovascular closure device 230. Furthermore, indicator 234 may includemarkings such as graduation markings including a conforming graduation236 that indicates when a conforming force is applied to vascularclosure device 230 through elongated body 200 and biasing member 180.Similarly, deformation of biasing member 180 may also providediscernable visual that a conforming force has been applied to vascularclosure device 230.

Indicator 234 may be constructed and arranged such that it issubstantially obscured when biasing member 180 is not compressed betweenprotrusion 210 and proximal surface 156 but become discernible when aconforming force is applied to elongated body 200 through biasing member180. Similarly, biasing member 180 may be constructed and arranged suchthat the amount of force required to compress a particular biasingmember 180 is substantially equivalent to a conforming force for aparticular vascular closure device 230.

Once the operator discerns that a conforming force has been applied tovascular closure device 230, the operator can inspect the treatment siteto verify that fluid or blood flow through hole 1016 has beensubstantially stopped. If it has, the operator can proceed withcompleting the closure of hole 1016. While the operator continues tomaintain the conforming force on vascular closure device 230, theoperator advances packing member 130 and locking member 222 towards hole1016 in vessel wall 1008 by advancing pushing member 132 along elongatedbody 200 until packing member 130 is compressed between outer surface1012 of vessel wall 1008 and locking member 222 engages elongated body200, for example, by passing over protrusion 224. This is illustrated inFIG. 22

When the operator is pleased with the positioning of packing member 130,such as when packing member 130 is coupled to the vessel 1006 by lockingmember 222, the operator severs elongated body 200 so as to leavevascular closure device 230 in position against inner surface 1010 ofvessel wall 1008 with packing member 130 positioned against outersurface 1012 of vessel wall 1008 and a portion of elongated body 200 intensions between vascular closure device 230 and locking member 222 withpacking member 130 in-between. In this configuration, the portion ofelongated body 200 left in situ continues to exert a conforming force onvascular closure device 230 and packing member 130 so as tosubstantially occlude hole 1016 in vessel wall 1008.

FIG. 24 illustrates application of a deforming force. Indicator 234 mayoptionally include deforming graduation 238 that is located on indicator234 to indicate when a deforming force greater than a conforming forceand sufficient to deforming the vascular closure device such that it maynot occlude hole 1016 is applied to vascular closure device throughelongated body 200 and biasing member 180.

While other devices rely on a clot forming at the opening in the wall ofthe vessel, and thus result in substantial oozing from the opening whilea clot is forming, embodiments such as those noted above cover theinside of the opening. Closure is maintained by tension on the seal, andby deforming the seal so that a portion of it is held against the vesselby the reaction of the seal to the deformation.

While the subject matter herein has been illustrated and described indetail in the exemplary drawings and foregoing description, the same isto be considered as illustrative and not restrictive in character, itbeing understood that only the preferred embodiment(s) have been shownand described and that all changes and modifications that come withinthe spirit of the disclosure are desired to be protected. It will beunderstood that structures, methods or other features describedparticularly with one embodiment can be similarly used or incorporatedin or with respect to other embodiments.

1. An apparatus for occluding a hole in a vessel wall, wherein anintroducer defining a lumen passes through the hole from the outside ofthe vessel to the inside of the vessel, the apparatus comprising: anassembly having a predeployment state and a deployed state, saidassembly comprising: a sleeve assembly defining a bore, wherein saidsleeve assembly is adapted to be inserted into the lumen of theintroducer; a pliant vascular closure device having a predeploymentconfiguration wherein said pliant vascular closure device is deformed tofit within the bore of said sleeve assembly and a deployed state whereinsaid pliant vascular closure device is too large to fit within the boreof said sleeve assembly without deforming said pliant vascular closuredevice; an elongated body coupled to said pliant vascular closuredevice; and a biasing member connecting said elongated body to saidsleeve assembly such that retracting said sleeve assembly away from saidvascular closure device when said vascular closure device is deployedwithin the body of the patient applies tension to said elongated bodyand elastically deforms said biasing member and exerts a force on saidvascular closure device.
 2. The apparatus of claim 1, whereinapplication of a conforming force through said elongated body to saidpliant vascular closure device deforms said pliant vascular closuredevice to conform against the vessel wall.
 3. The apparatus of claim 2,wherein conforming said pliant vascular closure device against saidvessel wall fluidly seals the hole in the vessel wall.
 4. The apparatusof claim 2, further comprising an indicator coupled to said elongatedbody, wherein said indicator is positioned to be substantially obscuredby said sleeve assembly when a force less than said conforming force isapplied to said pliant vascular closure device through said elongatedbody and wherein said indicator is positioned to be discernible whensaid conforming force is applied to said pliant vascular closure devicethrough said elongated body.
 5. The apparatus of claim 1, wherein, inthe deployed state, said pliant vascular closure device defines asymmetrical dome shape.
 6. The apparatus of claim 1, wherein said sleeveassembly is adapted to be inserted into the lumen of the introducerlocated in the hole in the vessel wall and wherein said sleeve assemblyis adapted to deploy said vascular closure device out of the introducersheath into the vessel, wherein said sleeve assembly is adapted to bewithdrawn from the hole with the introducer sheath, wherein said sleeveassembly further comprises a flange adapted to abut the introducersheath and block the sleeve assembly from passing through the introducersheath such that the introducer sheath may be used as a grip to retractsaid sleeve assembly away from said vascular closure device.
 7. Theapparatus of claim 6, wherein said elongated body extends through theintroducer when tension is applied to said elongated body by retractingsaid sleeve assembly away from said pliant vascular closure device. 8.The apparatus of claim 1, wherein said biasing member is positioned onthe proximal end of the sleeve assembly with the elongated bodyextending through said biasing member and said sleeve assembly, whereinsaid biasing member is constructed and arranged to longitudinallycompress when tension is applied to said elongated body by retractingsaid sleeve assembly away from said pliant vascular closure device. 9.The apparatus of claim 1, wherein said biasing member is positioned onthe proximal end of said elongated body with the biasing memberextending through said sleeve assembly, wherein said biasing member isconstructed and arranged to lengthen longitudinally when tension isapplied to said elongated body by retracting said sleeve assembly awayfrom said pliant vascular closure device.
 10. An apparatus for occludinga hole in a vessel wall of a vessel, wherein an introducer defining alumen passes through the hole from the outside of the vessel to theinside of the vessel, the apparatus comprising: an assembly having apredeployment state and a deployed state, said assembly comprising: asleeve assembly defining a bore, wherein said sleeve assembly is adaptedto be inserted into the lumen of the introducer; a pliant vascularclosure device; an elongated body coupled to said pliant vascularclosure device; and a biasing member connecting said elongated body tosaid sleeve assembly such that retracting said sleeve assembly away fromsaid vascular closure device when said vascular closure device isdeployed within the body of the patient applies tension to saidelongated body and elastically deforms said biasing member and exerts aforce on said vascular closure device and wherein application of aconforming force through said elongated body to said pliant vascularclosure device deforms said pliant vascular closure device to conformagainst the vessel wall.
 11. The apparatus of claim 10, whereinconforming said pliant vascular closure device against said vessel wallfluidly seals the hole in the vessel wall.
 12. The apparatus of claim10, further comprising an indicator coupled to said elongated body,wherein said indicator is positioned to be substantially obscured bysaid sleeve assembly when a force less than said conforming force isapplied to said pliant vascular closure device through said elongatedbody and wherein said indicator is positioned to be discernible whensaid conforming force is applied to said pliant vascular closure devicethrough said elongated body.
 13. The apparatus of claim 10, wherein, inthe deployed state, said pliant vascular closure device defines asymmetrical dome shape.
 14. The apparatus of claim 10, wherein saidsleeve assembly is adapted to be inserted into the lumen of theintroducer located in the hole in the vessel wall and wherein saidsleeve assembly is adapted to deploy said vascular closure device out ofthe introducer sheath into the vessel, wherein said sleeve assembly isadapted to be withdrawn from the hole with the introducer sheath,wherein said sleeve assembly further comprises a flange adapted to abutthe introducer sheath and block the sleeve assembly from passing throughthe introducer sheath such that the introducer sheath may be used as agrip to retract said sleeve assembly away from said vascular closuredevice.
 15. The apparatus of claim 14, wherein said elongated bodyextends through the introducer when tension is applied to said elongatedbody by retracting said sleeve assembly away from said pliant vascularclosure device.
 16. The apparatus of claim 10, further comprising apacking member arranged on said elongated member and constructed andarranged to be longitudinally displaced with respect to said elongatedmember to abut the vessel wall, wherein said packing member comprises amaterial suitable for implantation within the body of a patient whileabutting the vessel wall.
 17. The apparatus of claim 16, whereinconforming said pliant vascular closure device against said vessel wallfluidly seals the hole in the vessel wall before said packing memberabuts the vessel wall.
 18. An apparatus for occluding a hole in a vesselwall of a vessel, wherein an introducer defining a lumen passes throughthe hole from the outside of the vessel to the inside of the vessel, theapparatus comprising: an assembly having a predeployment state and adeployed state, said assembly comprising: a sleeve assembly defining abore, wherein said sleeve assembly is adapted to be inserted into thelumen of the introducer; a pliant vascular closure device; an elongatedbody coupled to said pliant vascular closure device; and a biasingmember connecting said elongated body to said sleeve assembly such thatretracting said sleeve assembly away from said vascular closure devicewhen said vascular closure device is deployed within the body of thepatient applies tension to said elongated body and elastically deformssaid biasing member and exerts a force on said vascular closure device,wherein application of a conforming force through said elongated body tosaid pliant vascular closure device deforms said pliant vascular closuredevice to conform against the vessel wall, wherein said sleeve assemblyis adapted to be inserted into the lumen of the introducer located inthe hole in the vessel wall and wherein said sleeve assembly is adaptedto deploy said vascular closure device out of the introducer sheath intothe vessel, wherein said sleeve assembly is adapted to be withdrawn fromthe hole with the introducer sheath, wherein said sleeve assemblyfurther comprises a flange adapted to abut the introducer sheath andblock the sleeve assembly from passing through the introducer sheathsuch that the introducer sheath may be used as a grip to retract saidsleeve assembly away from said vascular closure device.
 19. Theapparatus of claim 18, wherein conforming said pliant vascular closuredevice against said vessel wall fluidly seals the hole in the vesselwall.
 20. The apparatus of claim 18, further comprising an indicatorcoupled to said elongated body, wherein said indicator is positioned tobe substantially obscured by said sleeve assembly when a force less thansaid conforming force is applied to said pliant vascular closure devicethrough said elongated body and wherein said indicator is positioned tobe discernible when said conforming force is applied to said pliantvascular closure device through said elongated body.